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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds
Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners. -
Power List 2018
APRIL 2018 # 40 Editorial Upfront In My View Sitting Down With Stop and look at how far Preparing for the EU’s new What can algae teach us Sophie Kornowski-Bonnet, the industry has come data protection regulation about medicine design? Roche Partnering 09 10 – 11 20 – 21 50 – 51 100 Power List 2018 www.themedicinemaker.com Continuous Growth Fibra-Cel® disks—3-D growth matrix for perfusion and continuous processes Suspend your disbelief: > Less susceptible to shear forces, The three-dimensional Fibra-Cel matrix clogging, and fouling entraps anchorage dependent and > Ideal for secreted product and vaccine suspension cells—for optimized growth production conditions and increased yields. > Suitable for GMP production > For use in autoclavable, sterilize-in- place or BioBLU® Single-Use Vessels www.eppendorf.com/Fibra-Cel Fibra-Cel® is a registered trademark owned by Imerys Minerals California, Inc., USA and licensed to Eppendorf, Inc., USA. Eppendorf®, the Eppendorf Brand Design and BioBLU® are registered trademarks of Eppendorf AG, Germany. All rights reserved, including graphics and images. Copyright © 2018 by Eppendorf AG. tmm_epp_ad_210x266_2018_04.indd 1 28.03.18 13:34 Online this Month The Power List The 2018 Power List, starting on page 24 of this issue, features 100 of the most inspirational professionals involved in A Scientist Walks into a Bar... format to the public”. Generally, drug development. The list was compiled it involves scientists speaking on a based on reader nominations and And gives a presentation as part variety of topics, from medicine, to feedback from a judging panel – but any of Pint of Science, a global science neuroscience, to robotics and more, in list will always be subjective. -
AMGEN INC. V. SANOFI
Case: 20-1074 Document: 159 Page: 1 Filed: 06/21/2021 NOTE: This order is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC., Plaintiffs-Appellants v. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC, Defendants-Appellees ______________________ 2020-1074 ______________________ Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv- 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA, Judge Richard G. Andrews. ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for plaintiffs-ap- pellants. Also represented by SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG, STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou- sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott Case: 20-1074 Document: 159 Page: 2 Filed: 06/21/2021 2 AMGEN INC. v. SANOFI Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler Onorato Mead & Sears LLP, Washington, DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff- appellant Amgen Inc. also represented by SARAH CHAPIN COLUMBIA, McDermott, Will & Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA. MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, filed a response for defendants-appellees. Also represented by VICTORIA REINES; DAVID K. BARR, DANIEL REISNER, New York, NY; DEBORAH E. -
Health Advisory
Health Advisory July 2, 2021 • Information for Pierce County Healthcare Providers Communicable Disease Control Communicable Disease Control • (253) 649-1412 3629 S. D St. • Tacoma, WA 98418 (253) 649-1412 • (253) 649-1358 (fax) COVID-19 Updates for Providers Requested actions • Be aware Washington State Department of Health (DOH) issued a behavioral health provider alert about Fourth of July celebrations and other summertime gatherings. The alert asks providers to give patients information about safe social behaviors and the potential negative effects of impulsive behaviors following the state’s full reopening and the misperception that the COVID-19 pandemic has ended. • Be aware the U.S. Food and Drug Administration (FDA) updated the following Emergency Use Authorization (EUA) fact sheets to include the possible risk of pericarditis and myocarditis following vaccination: o Pfizer fact sheet for healthcare providers. o Pfizer fact sheet for patients. o Moderna fact sheet for healthcare providers. o Moderna fact sheet for patients. • Continue to report any case of myocarditis and pericarditis among people who received COVID-19 mRNA vaccine within the last 2 weeks. o Promptly report cases to the U.S. Vaccine Adverse Events Reporting System (VAERS). o Report cases to the Health Department’s 24-hour reporting line at (253) 649-1413. Include vaccine manufacturer, vaccine lot number, vaccination date, dose number, patient gender, age and history of prior SARS-CoV-2 infection. • Be aware the FDA extended the shelf life of Janssen (Johnson & Johnson) COVID-19 vaccine from 3 months to 4½ months. Visit Janssen’s lot expiry checker to determine the updated expiration of your vaccine. -
1 UNITED STATES DISTRICT COURT DISTRICT of MINNESOTA Shirley
CASE 0:10-cv-01821-JNE-JJK Document 65 Filed 04/05/11 Page 1 of 5 UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA Shirley Venus Shannon, Plaintiff, v. Civil No. 10-1821 (JNE/JJK) ORDER Baxter Healthcare Corporation, Hospira, Inc., and Abbott Laboratories, Inc., Defendants. In April 2010, Shirley Venus Shannon brought this action against Eli Lilly & Company and several unidentified entities. In October 2010, she filed an Amended Complaint against Baxter Healthcare Corporation, Hospira, Inc., and Abbott Laboratories, Inc. Abbott Laboratories and Hospira moved to dismiss the case for improper venue, see Fed. R. Civ. P. 12(b)(3); moved to dismiss the case for failure to state a claim upon which relief can be granted, see Fed. R. Civ. P. 12(b)(6); and moved to transfer the case to the United States District Court for the Northern District of Illinois, Eastern Division, see 28 U.S.C. § 1404(a) (2006). After answering, Baxter Healthcare joined the motions of Abbott Laboratories and Hospira. Baxter Healthcare did not separately submit memoranda of law. Shannon opposed the motions, but she asserted that the case should be transferred to the United States District Court for the Western District of Tennessee, Western Division. For the reasons set forth below, the Court transfers this action to the Western District of Tennessee. The Court first considers whether this case should be dismissed for improper venue. See Fed. R. Civ. P. 12(b)(3). The defendant bears the burden of establishing improper venue. United States v. Orshek, 164 F.2d 741, 742 (8th Cir. -
United States Court of Appeals for The
Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page1 of 37 14‐4353‐cv Apotex Inc., et al., v. Acorda Therapeutics, Inc. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term, 2015 (Argued: November 12, 2015 Decided: May 16, 2016) Docket No. 14‐4353‐cv ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x APOTEX INC., et al., Plaintiffs‐Appellants, ‐ v.‐ ACORDA THERAPEUTICS, INC., Defendant‐Appellee. ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x Before: JACOBS, LIVINGSTON and DRONEY, Circuit Judges. This appeal concerns two distinct questions: the circumstances under which the filing of a citizen petition with the Food and Drug Administration provides grounds for an antitrust claim, and the scope of false advertising Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page2 of 37 liability under the Lanham Act. Plaintiffs Apotex Incorporated and Apotex Corporation appeal from the judgment of the United States District Court for the Southern District of New York (Swain, J.) that granted defendant Acorda Therapeutics, Inc.’s motion to dismiss plaintiffs’ Sherman Act claim and that granted summary judgment in favor of defendant on the Lanham Act claims (Torres, J.). Because each of these conclusions was sound, we affirm. KEITH D. PARR (with Joseph N. Froehlich, Scott B. Feder, Hugh S. Balsam, James T. Peterka, and Andy J. Miller on the brief), Locke Lord LLP, Chicago, Illinois, for Appellants Apotex Incorporated & Apotex Corporation. JOHN W. NIELDS, JR. (with Jason C. Raofield and Colin P. Watson on the brief), Covington & Burling LLP, Washington, D.C. for Appellee Acorda Therapeutics, Inc. DENNIS JACOBS, Circuit Judge: The parties are rival manufacturers of tizanidine, a drug for treating spasticity. -
Abbott-Abbvie Multiple Employer Pension Plan
Abbott-AbbVie Multiple Employer Pension Plan Summary Plan Description Effective January 1, 2013 This summary plan description (SPD) describes the key features of the Abbott-AbbVie Multiple Employer Pension Plan effective January 1, 2013. This booklet describes only the highlights of the plan and does not attempt to cover all administrative details. Every attempt has been made to communicate this information clearly and in easily understandable terms. Benefits and services described here apply only to those former employees and retirees eligible for benefits under the plan. The boards of directors of the companies, or when applicable, the Abbott-AbbVie Pension Plan Administrative Committee, reserve the right to modify, suspend or terminate these benefits at any time to the extent permitted by law. This SPD does not constitute a contract of employment or guarantee any particular benefit. The terms of the Abbott-AbbVie Multiple Employer Pension Plan are governed by the plan and trust documents. In case of a conflict between this SPD and those documents, the plan and trust documents will control. Table of Contents Introduction................................................................................................................................................. 1 Eligibility ..................................................................................................................................................... 1 Eligible Employees ................................................................................................................................ -
Pfizer Inr 235 East 42Nd Street New York
Pfizer Inr 235 East 42nd Street New York. !W 10007-5755 March 25,2008 Steven Reynolds Director U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety 2443 Warrenville Road, STE 210 Lisle, IL 60532-4352 -Re: Parent Company Guarantee for Pharmacia Corporation (Chesterfield, MO and St. Louis, MO) Dear Mr. Reynolds: I am the Chief Executive Officer of Pfizer Inc. located at 235 East 42"d Street in New York, NY 10017. This letter is in support of this firm's use of the financial test to demonstrate financial assurance, as specified in 10 CFR Part 30. I hereby certify that Pfizer Inc. is currently a going concern, and that it possesses positive tangible net worth in the amount of $23,129,000,000. This firm is required to file a Form 10K with the U.S. Securities and Exchange Commission for the latest fiscal year. The fiscal year of this firm ends on December 3 1. I hereby certify that the content of this letter is true and correct to the best of my knowledge. panof the Board C ief Executive Officer Pfizer lnr 235 East 42nd Street New York, NY 10007-5755 March 25. 2008 Steven Reynolds Director U.S. Nuclear Regulatory Coinmission Division of Nuclear Material Safet) 2443 Warrenville Road STE 2 IO Lisle. IL 60532-4352 -Re: Financial Assurance Demonstration for Pharmacia Corporation (Chesterfield, MO and St. Louis, MO) Dear Mr. Reynolds: I am the chief financial officer of Pfizer Inc., 235 East 42'ld Street, New York. New York 10017, a corporation. This letter is in support of this firm's use of the parent company guarantee financial test to demonstrate financial assurance, as specified in IO CFR Part 30. -
List of Section 13F Securities
List of Section 13F Securities 1st Quarter FY 2004 Copyright (c) 2004 American Bankers Association. CUSIP Numbers and descriptions are used with permission by Standard & Poors CUSIP Service Bureau, a division of The McGraw-Hill Companies, Inc. All rights reserved. No redistribution without permission from Standard & Poors CUSIP Service Bureau. Standard & Poors CUSIP Service Bureau does not guarantee the accuracy or completeness of the CUSIP Numbers and standard descriptions included herein and neither the American Bankers Association nor Standard & Poor's CUSIP Service Bureau shall be responsible for any errors, omissions or damages arising out of the use of such information. U.S. Securities and Exchange Commission OFFICIAL LIST OF SECTION 13(f) SECURITIES USER INFORMATION SHEET General This list of “Section 13(f) securities” as defined by Rule 13f-1(c) [17 CFR 240.13f-1(c)] is made available to the public pursuant to Section13 (f) (3) of the Securities Exchange Act of 1934 [15 USC 78m(f) (3)]. It is made available for use in the preparation of reports filed with the Securities and Exhange Commission pursuant to Rule 13f-1 [17 CFR 240.13f-1] under Section 13(f) of the Securities Exchange Act of 1934. An updated list is published on a quarterly basis. This list is current as of March 15, 2004, and may be relied on by institutional investment managers filing Form 13F reports for the calendar quarter ending March 31, 2004. Institutional investment managers should report holdings--number of shares and fair market value--as of the last day of the calendar quarter as required by Section 13(f)(1) and Rule 13f-1 thereunder. -
Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S. -
Companies in Attendance
COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology, -
Research and Development at the University of Maryland Baltimore
RESEARCH AND DEVELOPMENT AT THE UNIVERSITY OF MARYLAND BALTIMORE FISCAL YEAR 2002 ANNUAL REPORT ANNUAL REPORT TABLE OF CONTENTS Overview 1 Extramural Funding at UMB 1 Office of Research and Development Outcomes 2 Success by School 6 Areas of Strength 13 Technology Commercialization 14 New Initiatives 19 Appendixes 20 David J. Ramsay, DM, DPhil President James L. Hughes Vice President, Research & Development www.ord.umaryland.edu RESEARCH AND DEVELOPMENT AT THE UNIVERSITY OF MARYLAND BALTIMORE ANNUAL REPORT FY 02 RESEARCH AND DEVELOPMENT AT THE UNIVERSITY OF MARYLAND BALTIMORE FISCAL YEAR 2002 ANNUAL REPORT OVERVIEW The University of Maryland Baltimore reached a milestone number in extramural funding in FY 02: $305.3 million. The research conducted on campus and the hundreds of projects funded from federal, state and local governments and the private sector demonstrate UMB’s ever-increasing contribution to the life sciences and health care research fields. As an economic engine for Maryland, UMB provides access to millions of dollars of research to the business community. The commercial potential for much of this work is being actively patented and licensed. Summary of Success Principal Investigators with Awards: 617 Principal Investigators with $1 million Plus in Awards: 44 Funding Applications: 2,274 Funding Awards: 1,673 Total Dollar Amount of Extramural Funding: $305.3 Million Total Dollar Amount of Extramural Funding through ORD: $250 Million % of Total Extramural Funding: 82% Volume of Federal Awards: $142.7 Million NIH Funding Amount: $127.2 Million % of Indirect Costs: 22.8% EXTRAMURAL FUNDING AT UMB Support for extramural funding at the UMB campus has tripled in the last eight years.